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API SUPPLIERS
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USDMF
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API Imports and Exports
INTERMEDIATE SUPPLIERS
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Evonik
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Acamprosate Calcium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Acamprosate Calcium manufacturer or Acamprosate Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acamprosate Calcium manufacturer or Acamprosate Calcium supplier.
PharmaCompass also assists you with knowing the Acamprosate Calcium API Price utilized in the formulation of products. Acamprosate Calcium API Price is not always fixed or binding as the Acamprosate Calcium Price is obtained through a variety of data sources. The Acamprosate Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acamprosate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acamprosate, including repackagers and relabelers. The FDA regulates Acamprosate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acamprosate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Acamprosate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acamprosate supplier is an individual or a company that provides Acamprosate active pharmaceutical ingredient (API) or Acamprosate finished formulations upon request. The Acamprosate suppliers may include Acamprosate API manufacturers, exporters, distributors and traders.
click here to find a list of Acamprosate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acamprosate DMF (Drug Master File) is a document detailing the whole manufacturing process of Acamprosate active pharmaceutical ingredient (API) in detail. Different forms of Acamprosate DMFs exist exist since differing nations have different regulations, such as Acamprosate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acamprosate DMF submitted to regulatory agencies in the US is known as a USDMF. Acamprosate USDMF includes data on Acamprosate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acamprosate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acamprosate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Acamprosate Drug Master File in Korea (Acamprosate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acamprosate. The MFDS reviews the Acamprosate KDMF as part of the drug registration process and uses the information provided in the Acamprosate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acamprosate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Acamprosate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acamprosate suppliers with KDMF on PharmaCompass.
A Acamprosate CEP of the European Pharmacopoeia monograph is often referred to as a Acamprosate Certificate of Suitability (COS). The purpose of a Acamprosate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acamprosate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acamprosate to their clients by showing that a Acamprosate CEP has been issued for it. The manufacturer submits a Acamprosate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acamprosate CEP holder for the record. Additionally, the data presented in the Acamprosate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acamprosate DMF.
A Acamprosate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acamprosate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Acamprosate suppliers with CEP (COS) on PharmaCompass.
A Acamprosate written confirmation (Acamprosate WC) is an official document issued by a regulatory agency to a Acamprosate manufacturer, verifying that the manufacturing facility of a Acamprosate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acamprosate APIs or Acamprosate finished pharmaceutical products to another nation, regulatory agencies frequently require a Acamprosate WC (written confirmation) as part of the regulatory process.
click here to find a list of Acamprosate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Acamprosate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acamprosate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Acamprosate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Acamprosate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acamprosate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acamprosate suppliers with NDC on PharmaCompass.
Acamprosate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Acamprosate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Acamprosate GMP manufacturer or Acamprosate GMP API supplier for your needs.
A Acamprosate CoA (Certificate of Analysis) is a formal document that attests to Acamprosate's compliance with Acamprosate specifications and serves as a tool for batch-level quality control.
Acamprosate CoA mostly includes findings from lab analyses of a specific batch. For each Acamprosate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Acamprosate may be tested according to a variety of international standards, such as European Pharmacopoeia (Acamprosate EP), Acamprosate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acamprosate USP).
